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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCOLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING
Generic NameMATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
ApplicantINTEGRA LIFESCIENCES CORP.
311 ENTERPRISE DR.
PLAINSBORO, NJ 08536
PMA NumberP840062
Supplement NumberS022
Date Received08/18/2011
Decision Date03/19/2012
Product Code LPG 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF AN ADDITIONAL TRADE MAME, FROM ORACOTE, TO THE COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY PRODUCTS.
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